Coffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?

NCT01079442 — Not applicable, Completed, 80 participants, Heidelberg University

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Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?

Registry	NCT01079442
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	80 (Actual)
Sponsor	Heidelberg University (Other)
Conditions	Colectomy
Interventions	Postoperative coffee, water (Other)
Dates	start 2010-03-01, primary completion 2011-03-01, completion 2011-03-01, first posted 2010-03-03, last updated 2011-09-30
Locations	3 sites in Germany

-Summary

The purpose of the investigators study is to investigate the effects of coffee on the return of bowel function and appetite, length of hospital stay, and complications after elective open colectomy in a prospective randomized trial. The primary efficacy endpoint is time to first bowel movement.

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+Detailed description

Coffee is a popular beverage. Its effects on general well being, central nervous system and cardiovascular system are well known, but there is limited information regarding its effects on gastrointestinal function.

+Arms and interventions

Arm	Type	Interventions	Description
Treatment arm: coffee	Active comparator	Other: Postoperative coffee	coffee administration
Water arm	Placebo comparator	Other: water	The control drink consists of 100 ml warm water

Postoperative coffee (Other), also known as Lavazza Blue Espresso Dolce 100% Arabica coffee: schedule for coffee administration for the present trial was chosen as follows (starting 6 hours postoperatively): * 08:00 100mL beverage * 12:00 100mL beverage * 16:00 100mL beverage
water (Other), also known as tap water: The control drink consists of 100 ml warm water which is administered according a same fixed schedule as Group A starting 6 hours postoperatively: * 08:00 100mL beverage * 12:00 100mL beverage * 16:00 100mL beverage

+Outcome measures

Primary outcomes

Time to first bowel movement [patients postoperative in hospital stay (mean 6 days)]: Time from end of surgery until patient's first bowel movement (i.e. passage of stool).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients scheduled for elective open or laparoscopic colectomy
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria:

* Participation in concurrent intervention trials
* Need for a stoma
* Known hypersensitivity or allergy to coffee
* Expected lack of compliance
* Impaired mental state or language problems
* change in surgical procedure

+Locations (3)

Facility	City	Country
Salem Krankenhaus	Heidelberg	Germany
University hospital	Heidelberg	Germany
Kreiskrankenhaus GRN Sinsheim	Sinsheim	Germany

+Publications

Results publication: Muller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler MW. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012 Nov;99(11):1530-8. doi: 10.1002/bjs.8885. Epub 2012 Sep 14. PMID 22987303

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